Hyperglycemia is a condition associated with various diseases conditions. One of the most prominent disease states with hyperglycemia as a symptom is diabetes mellitus. Diabetes mellitus is a systemic disease which starts with continuous high levels of blood glucose. A healthy person typically controls the levels of blood glucose by the hormone insulin and keeps the blood glucose levels in between about 80 to about 100 mg/dl in hungry status. In patients with diabetes blood glucose levels can exceed 125 mg/dl.
Since the first therapeutic use of insulin, diabetes mellitus has been a treatable but chronic disease condition, and the main health risks are the characteristic long-term complications associated with the disease. These include an increased risk for cardiovascular diseases, chronic renal failure, retinal damage possibly resulting in blindness, nerve damage, erectile dysfunction (impotence) and gangrene with risk of amputation. One assay usually used to test for diabetes, but also for insulin resistance, is the glucose tolerance test. The glucose tolerance test in medical practice measures how quickly administered glucose is cleared from the blood. The glucose is most often given orally so the common test is technically an oral glucose tolerance test (OGTT). There are several drugs available for the treatment of diabetes. Oral drugs for the treatment of diabetes mellitus are classified in four categories. Within the first category are inhibitors of glucose absorption, e.g., alpha glucosidase inhibitors. In the second category are inhibitors of glucose production in the liver, e.g., biguanide. The third category includes drugs that improve the insulin sensitivity of the body, e.g., thiazolidine derivatives. To the fourth category belong stimulators of insulin secretion, e.g., sulfonyl urea or tenaglinid. These drugs are essentially dependent on the effects of insulin controlling glucose metabolism.
For improvement of the health status of an individual in general, numerous food supplements are available. Usually they are based on the use of vitamins and other metabolically relevant substances. Some of these also claim to be beneficial for patients suffering from diabetes or diabetes related conditions. For example, in US Patent application US 2002155163, it has been proposed that a daily multi-vitamin and mineral combination can be of use in the adjunct care of humans with diabetes. The composition comprises thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, choline, inositol, para-amino benzoic acid, vitamin C, calcium, magnesium, iodine, selenium, manganese, chromium, molybdenum, boron, zinc, potassium, silicon, sulfur, vanadium, citrus bioflavonoid complex, hesperidin complex, rutin, vitamin A, vitamin D, vitamin E, lycopene, lutein, coenzyme Q10 and alpha-lipoic acid. In another example it has been proposed to use for treatment of diabetic neuropathy a pharmaceutical composition comprising as active ingredients vitamin C, vitamin E, Gingko biloba and at least one substance selected from the group consisting of a vitamin, a mineral, an amino acid and a herb, and also includes a physiologically acceptable pharmaceutical carrier or diluent (WO 2005/117924).
In the past, the common practice to include numerous metabolically relevant ingredients in food supplements for improvement of nutrition and to promote general well being has led to compositions comprising dozens of substances without verification of whether these substances in combination really provide beneficial effects for the patient or not. Even worse, sometimes the erratic combination of unlimited ingredients can cause serious adverse effects in the consumer. Therefore, it becomes more and more apparent that the ingredients in such compositions should preferably not be combined at random but selected carefully and based on profound knowledge.
Thus, for the prevention and/or treatment of hyperglycemia-related diseases such as diabetes there is still a need for drugs and compositions that are easy to administer and that are pharmaceutically acceptable and have no or little adverse effects. In particular, drugs are needed that do not rely (or rely only to a small extent) on the effects of insulin, and that comprise a reasonable number of ingredients. Therefore, it is an object of the present invention to provide compositions effective in reducing blood glucose for the treatment and/or prophylaxis of hyperglycemia-related diseases such as diabetes.